SPL v1
SPL
SPL Set ID 69beb809-2eb6-4594-bae7-e2de7bea3d3f
Route
TOPICAL
Published
Effective Date 2020-05-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.1 g)
Inactive Ingredients
Water Hypochlorous Acid Sodium Benzoate Polysorbate 20 Citric Acid Monohydrate Butylene Glycol Aloe

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-01

Description

Benzalkonium chloride 0.1%

Purpose

SANITIZER


Medication Information

Purpose

SANITIZER

Description

Benzalkonium chloride 0.1%

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

For external use only.

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Do not use

• in children less than 2 months of age

• on open skin wounds

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When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

• Wet hands thoroughly with product and allow to dry without wiping

Active Ingredient

Benzalkonium chloride 0.1%

Other Information

• Store between 0-30C

Inactive Ingredients

Water, Hypochlorous Acid, Sodium benzoate, Polysorbate-20, Citric acid, 1,3-Butylene Glycol, Fragrance, Aloe Extract

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label : Mom Ae Sog for Zero 60 Wipes


Structured Label Content

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease.

Purpose (PURPOSE)

SANITIZER

Warnings (WARNINGS)

For external use only.

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Do not use

• in children less than 2 months of age

• on open skin wounds

--------------------------------------------------------------------------------------------------------

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Directions

• Wet hands thoroughly with product and allow to dry without wiping

Active Ingredient (ACTIVE INGREDIENT)

Benzalkonium chloride 0.1%

Other Information (Other information)

• Store between 0-30C

Inactive Ingredients (INACTIVE INGREDIENTS)

Water, Hypochlorous Acid, Sodium benzoate, Polysorbate-20, Citric acid, 1,3-Butylene Glycol, Fragrance, Aloe Extract

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contact a Poison Control Center right away.

Package Label : Mom Ae Sog for Zero 60 Wipes (Package Label : MOM AE SOG FOR ZERO - 60 wipes)


Advanced Ingredient Data


Raw Label Data

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